On November 7, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will present clinical data from its ongoing Phase 1b clinical trial at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in National Harbor, Maryland from November 7-9, 2025.

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Phio’s poster presentation will highlight the clinical results from the ongoing Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma, and melanoma.

Presentation Details are as follows:

Title: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: A Clinical Study of INTASYL PH-762
Abstract Number: 610
Presenting Author: Mary Spellman, M.D.
Date: Saturday November 8, 2025
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center

(Press release, Phio Pharmaceuticals, NOV 7, 2025, View Source [SID1234659643])

On November 7, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported new data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). A 40% objective response rate (ORR) was demonstrated in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma TMB (≥10 mutations/Mb), as well as a statistically significant correlation between plasma TMB status and response. These new clinical data are being presented in a late-breaking poster presentation (Abstract # 1315) today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place from November 5-9, 2025, in National Harbor, Maryland.

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"These compelling new Phase 2 data for vilastobart in combination with atezolizumab demonstrated a 40% objective response rate in heavily pre-pretreated patients with MSS mCRC without liver metastases and with high plasma TMB, signifying an important advance in our understanding of response to novel immunotherapy in MSS mCRC," said Katarina Luptakova, M.D., chief medical officer of Xilio. "In addition, these data showed a statistically significant correlation between plasma-based TMB and response. We estimate that approximately 55% of patients with MSS CRC have high plasma TMB, representing a meaningful patient population who could ultimately benefit from combination treatment with vilastobart and a substantially greater prevalence of patients with high TMB than previously estimated using traditional tissue-based assays."

"These new data highlight the potential to use plasma TMB as a predictive biomarker and identify patients with MSS mCRC who may benefit from treatment with vilastobart, a tumor-activated anti-CTLA-4, in combination with a PD-(L)1," said Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center. "This biomarker guided approach, utilizing a feasible and reproducible biomarker, together with vilastobart’s differentiated safety profile, continue to support the promising opportunity for vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC, as well as other tumor types."

Promising Opportunity for Plasma-Based TMB as a Biomarker Predictive of Response to Combination Treatment with Vilastobart in Patients with MSS mCRC

Tissue-based TMB has demonstrated potential as a biomarker predictive of response to immune checkpoint inhibitors in many tumor types. However, tissue-based TMB assays have not shown predictive utility in MSS mCRC historically, and these tissue-based assays may underestimate the mutational burden in patients. In particular, tissue-based assays are limited to evaluating mutations in a single-site biopsy specimen, which is typically taken once at the time of diagnosis, and cannot account for tumor heterogeneity or changes in TMB over time.

Newer plasma-based assays show potential to better assess TMB status and be used as a biomarker predictive of response in patients with MSS mCRC. These plasma-based assays are more sensitive than traditional tissue-based assays in that plasma-based TMB assays provide a comprehensive assessment of mutational load and account for tumor heterogeneity. In addition, plasma can be readily obtained from blood samples throughout the course of treatment, accounting for changes in TMB over time without the need for invasive procedures.

Approximately 55% of non-MSI-H CRC patients were plasma TMB high (>10 mutations/Mb) based on an analysis of the GuardantINFORM real-world clinical-genomic database in approximately 8,000 patients who received the Guardant360 Liquid (Infinity) assay and who had non-MSI-H disease and a reportable TMB result. In contrast, historical data for tissue-based TMB assays have suggested <10% of patients with MSS mCRC were TMB-high.

These data support the meaningful opportunity to use plasma-based TMB as a biomarker predictive of response to combination treatment with vilastobart in patients with MSS mCRC.

New Data from Phase 2 Trial for Vilastobart in Combination with Atezolizumab in Patients with MSS mCRC Without Liver Metastases and with High Plasma TMB

As of a data cutoff date of May 12, 2025, 44 patients with MSS mCRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W), including 27 patients without liver metastases. Patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy.

In a retrospective analysis, 24 patients without liver metastases were evaluable for plasma TMB status. Baseline plasma TMB was assessed using the Guardant360 Liquid (Infinity) assay, and patients with TMB ≥10 mutations/Mb were defined as having high plasma TMB.

Clinical Efficacy Data

40% ORR in patients with MSS mCRC without liver metastases and high plasma TMB, with statistically significant correlation (p=0.05) between plasma TMB status and response.

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40% ORR in plasma TMB-high patients, consisting of six partial responses (PRs), with five confirmed PRs (with one confirmed after the data cutoff date) and one unconfirmed PR.

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In patients evaluable for plasma TMB status, 62.5% were TMB-high. All responders who were evaluable for plasma TMB status were TMB-high, and the correlation between plasma TMB status and response was statistically significant (p=0.05).

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As previously reported, responses were deep and durable, with reductions in target lesions of up to 71% from baseline.

Safety Data

Vilastobart in combination with atezolizumab continued to demonstrate a differentiated and generally well-tolerated safety profile. Treatment-related adverse events (AEs) were primarily Grade 1 or 2, consistent with the tumor-activated design for vilastobart.

As previously reported, across all patients treated as of a data cutoff date of May 12, 2025 (n=44), the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated. Treatment-related AEs were primarily Grade 1 or 2. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related AE, and only three patients (7%) experienced colitis of any grade.

Clinical Development Plans for Vilastobart

Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.

Investor Conference Call Information

Xilio will host a conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET. The webcast will feature a discussion with expert clinicians Aparna Parikh, M.D., Associate Professor of Medicine, Harvard Medical School, Program Director, GI Medical Oncology, Colorectal, Anal, and Neuroendocrine, Director of the MGB Global Cancer Care Program, Mass General Brigham Cancer Institute, Boston, MA, and Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center, Pittsburgh, PA. During the webcast, Xilio will discuss the new Phase 2 combination data for vilastobart and the promising opportunity to use high plasma TMB as a predictive biomarker for response, as well as briefly highlight additional data updates presented at SITC (Free SITC Whitepaper) across the company’s portfolio of differentiated masked immunotherapies.

Viewers can access the webcast by using this link. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under "Events & Presentations" in the "Investors & Media" section of the Xilio Therapeutics website at ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

About Vilastobart and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

(Press release, Xilio Therapeutics, NOV 7, 2025, View Source [SID1234659642])

On November 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2025.

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"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."

Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this press release, please click here.
On September 23, 2025, the Company announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor, given his extensive experience and relationships at the highest levels of government, including with U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. To view this press release, please click here.
On September 4, 2025, the Company announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax platform. To view this press release, please click here.
On August 18, 2025, the Company announced that the Office of Orphan Products Development of the FDA had granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet’s Disease" following review of positive Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2025

Soligenix reported no revenue for the quarters ended September 30, 2025 and 2024.

Soligenix’s net loss was $2.5 million, or ($0.58) per share, for the quarter ended September 30, 2025, compared to $1.7 million, or ($0.78) per share, for the quarter ended September 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in interest income and a CARES Act employee retention credit received during the three months ended September 30, 2024 with no corresponding employee retention credit received during the three months ended September 30, 2025.

Research and development expenses were $1.6 million for the quarter ended September 30, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial as well as increases in third party contract manufacturing.

General and administrative expenses were $1.0 million for the quarter ended September 30, 2025 as compared to $0.9 million for the same period in 2024. The decrease was primarily attributable to increases in professional expenses.

As of September 30, 2025, the Company’s cash position was approximately $10.5 million.

(Press release, Soligenix, NOV 7, 2025, View Source [SID1234659641])

On November 7, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented.

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"These data are important because they demonstrate that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade," said Kostas Xynos, M.D., Ph.D., Chief Medical Officer of Replimune. "Low T cell levels in tumors, tumor PD-L1 expression, T-cell activation and IFNy gene signature expression, as well as the loss of antigen presentation machinery are well known mechanisms of resistance to immune checkpoint blockade."

Data from the late-breaking abstract (#1327) presented by Trisha Wise-Draper, M.D., Ph.D., show:

Pharmacodynamic changes that were not achieved during prolonged prior anti–PD-1 therapy demonstrate that the addition of RP1 reverses multiple resistance mechanisms to PD-1 blockade and highlights the contribution of RP1 in melanoma patients who previously failed such treatment.
Treatment with RP1 plus nivolumab led to upregulation of gene signatures associated with responsiveness to PD-1 blockade.
With additional follow-up (7 months), RP1 combined with nivolumab continues to demonstrate a clinically meaningful response rate (ORR: 33.6%) and durability (median duration of response: 24.8 months).
Consistent duration of response was observed across PD-L1–positive and negative tumors, as well as in both primary and secondary resistance settings. Median duration of response for PD-L1-negative patients was 24.8 months and for patients with primary resistance was 22.6 months.
Additional posters being presented at the meeting include:

Abstract 611: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti-PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Katy Tsai, M.D.)
RP1 plus nivolumab demonstrated comparable efficacy in BRAF-mutant and BRAF–wild-type advanced melanoma.
Greater activity was observed in BRAF-naïve patients – similar to findings from the SECOMBIT and DREAMseq trials.
Abstract 600: Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1- failed melanoma (Gino K. In, M.D.)
Extended RP1 treatment beyond 8 doses was well tolerated providing clinical benefit in a majority of patients.
About IGNYTE
The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (≤10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, NOV 7, 2025, View Source [SID1234659640])

On November 7, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation therapies to treat cancer and immune disorders, reported the presentation of new translational data from its ongoing Phase 1 study of NX-1607, an oral, first-in-class inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting which is being held November 5–9, 2025, in National Harbor, MD.

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The poster, titled Translational Insights from a First-in-Human Study of an Oral CBL-B Inhibitor in Advanced Solid Tumors, expands upon data presented at the recent European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from heavily pretreated patients with a variety of tumor types who were treated with NX-1607 in an ongoing Phase 1a clinical trial. The new data presented at SITC (Free SITC Whitepaper) demonstrate that treatment with NX-1607 resulted in dose dependent pharmacologic activity consistent with target engagement and downstream immune modulation. Treatment with NX-1607 led to increased peripheral T cell activation and proliferation, which were statistically significantly greater in patients with stable disease (SD) compared with those with progressive disease (PD), indicative of active T-cell receptor (TCR) engagement and immune responsiveness to treatment.

The poster also highlights a case study of a patient with metastatic castration-resistant prostate cancer (mCRPC) who achieved a best response of stable disease while receiving NX-1607. Treatment was associated with expansion of activated peripheral memory T cell subsets, an increase in CD8+ tumor infiltrating lymphocyte (TIL) density and enhanced immune activation gene signatures in paired metastatic lymph node tumor biopsies. Collectively, these findings indicate that NX-1607 induced peripheral immune activation is associated with remodeling of the tumor microenvironment (TME), linking systemic immune activation to local tumor control.

"These translational findings further support the biological rationale for CBL-B inhibition as a novel immune-oncology therapy," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. "NX-1607 has demonstrated encouraging signs of immune activation and disease control in heavily pretreated patients, supporting its potential as a novel next generation checkpoint inhibitor therapy and its continued development as a monotherapy and in combination with other anticancer agents for the treatment of advanced solid tumors."

Key Findings

Dose-dependent pharmacology and immune activation: NX-1607 demonstrated dose-dependent pharmacokinetics and pharmacodynamic modulation of the proximal biomarker pHS1, confirming target engagement and inhibition of CBL-B–mediated signaling.
Peripheral immune activation linked to clinical benefit: Patients with stable disease exhibited a greater enrichment of circulating PD-1⁺ CD8⁺ T cells expressing Ki67⁺ (proliferation) and ICOS⁺(activation) markers compared with those with progressive disease, demonstrating active TCR engagement and antitumor immune responsiveness.
Remodeling of the tumor microenvironment: In a case study of a heavily pretreated mCRPC patient (5 prior therapies), NX-1607 treatment achieved a best response of stable disease. Paired pre and post treatment metastatic lymph node tumor biopsy analyses showed an increase in CD8⁺ TIL density, upregulation of cytotoxic and interferon-response pathways, and reduced regulatory T-cell signatures, consistent with enhanced effector activity and immune activation within the TME.
Transcriptomic evidence of immune pathway engagement: RNA sequencing analyses demonstrated dose-dependent enrichment of immune signaling pathways, including interferon response, antigen presentation, and effector T cell activation, further supporting a mechanistic link between NX-1607 exposure and immune activation.
About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

(Press release, Nurix Therapeutics, NOV 7, 2025, View Source [SID1234659639])